QMS Executive (Mandarin Speaker)

Quality Management System (QMS) :

Implement, maintain, and improve QMS processes and procedures in line with industry standards (e.g., ISO 9001, ISO 13485, etc.). Ensure manufacturing activities comply with all relevant internal policies and external regulatory requirements. Internal Audits & Risk Assessments :

Conduct regular internal audits and compliance assessments of manufacturing operations. Identify process risks, gaps, or deviations and initiate appropriate corrective measures. Non-Compliance Management :

Lead root cause analysis and investigations of non-conformities, deviations, and product quality issues. Collaborate with cross-functional teams to implement effective corrective and preventive actions (CAPA). CAPA Implementation :

Develop, execute, and monitor CAPA plans to ensure timely and sustainable resolution of compliance issues. Track effectiveness of actions taken and ensure closure within defined timelines. Training & Awareness :

Conduct training sessions for manufacturing staff on compliance protocols, standards, and best practices. Promote a culture of quality and compliance across the organization. Subject Matter Expert :

Serve as a key resource for compliance-related inquiries, audits, and improvement initiatives. Support external and customer audits by providing necessary documentation and process walkthroughs. Any ad hoc tasks assigned by management or company.

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